This research project seeks to learn more about how lifestyle interventions can help liver and kidney transplant recipients achieve weight loss goals. The investigators want to evaluate if an intervention using weight and activity wrist monitors, as well as nutritional coaching group sessions is acceptable and useful for post-transplant patients aiming for weight loss. All participants will be given a wrist activity monitor, and a scale. Half of participants will be invited to participate in the nutritional coaching group sessions. The research team will look at weight loss, devices' usage, and satisfaction, and see if there are any difference among the two groups.
This project aims to understand feasibility, acceptability, and appropriateness of using connected health services (use of Fitbit and Scale), and nutritional coaching group sessions as a lifestyle intervention for post-transplant patients seeking weight loss. Secondarily, the investigators aim to assess effectiveness of the intervention to generate weight loss. Enrolled patients will receive a wrist activity tracker (Fitbit Charge 4) and a scale, of which information synchronizes to the electronic health record. Steps, usage, and weight values will be recorded and analyzed from the devices. All patients will be followed with monthly calls to assess issues with devices, and address case-specific questions. Simultaneously, half of the patients will be randomized to receive every other month nutritional coaching group sessions on topics related to nutrition and physical activity. Patients will have an in-person follow-up appointment where laboratory values, body measurements, and physical and mental readiness for weight loss surveys and scales will be applied at 6 and 12-months. Patients that don't accomplish weight loss goal at 6 months will be invited to cross over to the nutritional coaching group sessions intervention arm.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
24
Wrist activity tracker used to evaluate number of steps, heart rate, and frequency of usage of the devices to monitor activity. Scale used to record a patient's weight value.
Nutritional coaching group sessions held via zoom and performed by a certified clinical nutritionist regarding nutrition, and physical activity specific for weight loss.
Massachusetts
Boston, Massachusetts, United States
Feasibility of intervention
The Feasibility of Intervention Measurement (FIM) is a previously-validated survey tool used in implementation science, and answered by participants, that uses a Likert scale from 1 to 5 to evaluate feasibility of the proposed intervention. A score greater than or equal to 4 is considered acceptable feasibility.
Time frame: 12 months (All study duration)
Acceptability of intervention
The Acceptability of Intervention Measurement (AIM) is a previously-validated survey tool used in implementation science, and answered by participants, that uses a Likert scale from 1 to 5 to evaluate acceptability of the proposed intervention. A score greater than or equal to 4 is considered adequate acceptability.
Time frame: 12 months (All study duration)
Rate of highly satisfied Patients
Patient-completed satisfaction questionnaires will be evaluated using a Likert scale from 1 to 5 with five being very satisfied and one being very unsatisfied. Satisfaction surveys were asked separately for the use of devices (Fitbit and smart scale), every other month follow-up calls, and every other month group sessions. An additional overall satisfaction score was also obtained for the entire intervention. High satisfaction will be considered the proportion of "somewhat satisfied" and "very satisfied" answers.
Time frame: 12 months (All study duration)
Wrist activity tracker usage rate
Usage rate will be calculated as the proportion of days in which steps are logged in relation to the number of days per month.
Time frame: 12 months (All study duration)
Weight change percentage
Target Weight change percentage will be considered a greater than or equal to 2.5% loss at 6 months, and greater than or equal to 5% weight loss over the course of the 12-month period.
Time frame: 12 months (All study duration)
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